The Good Clinical Trials Collaborative is organizing a community response to ensure new guideline helps trials to be informative, ethical and efficient

On Monday 22 May 2023, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a draft of its updated guideline for Good Clinical Practice. The ICH has invited members of the public to comment on the guidelines and stated that it expects “an extraordinarily large number of comments” in the consultation period.

Community response

The Good Clinical Trials Collaborative has therefore launched a community response process to ensure that diverse expert opinion, from a wide range of settings and perspectives, including from patient communities, is properly represented and has the opportunity to influence the final guideline.

Influential but flawed guideline

Older versions of the ICH Good Clinical Practice guideline have been internationally accepted standards that outline scientific, ethical and quality expectations for clinical trials involving humans. A globally unified standard has helped to facilitate mutual acceptance of clinical trial data between different countries but it has also been criticized.

Criticisms have included that the guideline gives insufficient guidance on how to apply the standards flexibly and proportionately, or that it focuses on specific processes without highlighting their relative importance or impact on the scientific or ethical quality of a trial, giving space for inappropriate rigidity or misinterpretation. This has led to a situation where it is widely agreed that unnecessary bureaucracy and defensiveness are holding back the potential of clinical trials to improve public health, and has limited opportunities to embrace innovative approaches or technologies. Ultimately, participants, patients and the public suffer when trials are designed, conducted, or regulated poorly.

Renovation and public consultation

The ICH has deliberately described this update as a ‘renovation’, an opportunity to thoroughly reappraise the guideline. The updated draft guideline, known formally as the ICH Harmonised Guideline Good Clinical Practice (GCP) E6(R3), is explicitly intended to address criticisms of previous versions by recognising the need for a principles-based approach that can be applied flexibly across trial types and settings, can incorporate technological and methodological advances, and helps trials to be fit for their intended purpose.

These high-level goals are important but it is critical that they are met in the final guideline as it will influence clinical trials globally for many years to come, during what is expected to be a period of immense technological innovation. Failure may hold up access to new treatments, limit our response to future health emergencies, and embed inefficiency and waste in our healthcare systems.

Get involved

The Good Clinical Trials Collaborative will share opportunities to get involved in the consultation process, and will also be inviting interested parties to help shape our community response and recommendations.

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